The tongue and soft palate play a major role in the production of snoring and obstructive sleep apnea, and their participation is needed to causes these symptoms to exist. Hence, it is imperative to have knowledge about these structures, which play a major important role in snoring and obstructive sleep apnea. Most of us do not think of snoring as something to be overly concerned about. However, frequent, loud snoring may be a sign of sleep apnea, a common and potentially serious disorder in which breathing repeatedly stops and starts as you sleep. These breathing pauses during sleep apnea last between 10 to 20 seconds and can occur up to hundreds of times a night.
Although sleep apnea is treatable, it often goes unrecognized. Untreated sleep apnea can be dangerous and detrimental to your health, so it's important to see a doctor if you suspect that you or a loved one might have it. Read on to learn the warning signs of sleep apnea, how to distinguish it from normal snoring, the medical treatments available, and what you can do to help yourself.
The tongue is a muscular-neuro-vascular body on the floors of the mouths of most vertebrates. It maneuvers food for mastication and is the primary organ of taste, through papillae and taste buds that cover the surface of the tongue. The tongue is kept moist by saliva and mucous glands of the mouth. It is supplied with nerves, lymphatics, and blood vessels. In humans, a secondary function of the tongue is phonetic articulation. The tongue serves as a natural means of cleaning one's teeth by its all-directional movement capacity. In mammals (dogs, cats and other animals), the tongue has a rough surface which is used to clean the fur and body. A dog's tongue acts as a heat regulator.
The average length of the human tongue in adults from the oropharynx to the tip is 10 cm (4 inches). It has 5 intrinsic muscles (superior, inferior, longitudinal, transverse & vertical) within the tongue that are not attached to any bone where the 4 extrinsic muscles are attached to the bones below the tongue. They are the genio, hyo, stylo, palato-glossus muscles. The primary blood supply to the tongue is from the lingual artery, a branch of the external carotid artery. There is a secondary blood supply to the tongue from the tonsillar branch of the facial artery and the ascending pharyngeal artery.
The underneath of the front of the tongue is called the sublingual region where the oral mucosa is very thin with a rich plexus of veins. This sublingual region is used as route of administration of many therapeutic agents. For example, this is the distinct expedient and efficacious route of administration of nitroglycerin to a patient suffering chest pain from angina pectoris. This medicine would be ineffective if swallowed.
The tongue is one of the most active skeletal muscles masses in the body, used from the minute one wakes up to the time one goes to sleep. Hence, the tongue is constantly subjected to trauma, whether intended or unintended. The tongue is constantly moving while eating, drinking, and talking as well as during other facial activities. Hence, the tongue is subject to trauma by the teeth and the physical forces of cold and hot temperature of substances as well as exposure to different chemicals consumed like alcohol, acids, alkalis and toothpaste, etc., which play a role in affecting the tongue and palate.
The tongue is supplied by many sensitive nerves, which can cause the gag reflex from a foreign object. Taste sensation for the anterior ⅔ of the tongue is supplied by the Facial nerve (Chorda tympani, CN VII). General sensation of the anterior ⅔ is supplied by the Lingual nerve which is a branch of V3 of the Trigeminal nerve CN V. Taste as well as general sensation for the posterior ⅓ is supplied by the Glossopharyngeal nerve (CN IX). All intrinsic and extrinsic muscles of the tongue are innervated by the Hypoglossal nerve (CN XII), except for one of the extrinsic muscle, palatoglossus that is innervated by CN X of the pharyngeal plexus. The internal laryngeal nerve, a branch of the vagus nerve, supplies the posterior part of the tongue. The tongue plays a primary role in the production of obstructive sleep apnea.
The palate forms the roof of the mouth, made up of the hard palate in front, and the soft palate behind. The hard palate formed by the palatine processes of the maxilla and the horizontal plates of the palatine bone. Behind, it is continuous with the soft palate. The upper surface of the hard palate forms part of the floor of the nasal cavity lined by ciliated epithelium.
There are five pairs of palatine muscles of the soft palate involved in the movement of the palate and uvula, which can participate in production of snoring. They are 1 Tensor palati; 2. levator palati 3. Palatopharyngeus from the upper surface, 4. With the uvular muscles within the upper surface. 5. Palatoglossus from the lower surface. The flexible skeleton for the soft palate is due to the aponeurosis of Tensor palati muscle.
It is the soft palate along with the tongue and oro-laryngo-pharynx which plays a role in snoring and obstructive sleep apnea. The soft palate is suspended from the posterior border of the hard palate, extends downwards, and backwards between the oral and nasal parts of the pharynx. The soft palate consists of mucous membrane enclosing an aponeurosis, muscular fibers, vessels, nerves, lymphoid tissue, and mucous glands. Its superior border is attached to the posterior margin of the hard palate, and its sides are blended with the pharynx. Its inferior border is free, and that is what contributes to snoring. The uvula is a small conical form which hangs from the middle of its lower border where there are two curved folds of mucous membrane, which contain muscular fibers (palatoglossal arch), and extend laterally and downwards from each side of the base of the uvula. A thin, firm, fibrous lamella, termed the palatine aponeurosis, supports the muscles and gives strength to the soft palate, which is attached to the posterior border of the hard palate and to the inferior surface of the hard palate behind the palatine crest. The muscles of the palate include a levator and a tensor of the palate. The muscles are underlying in the palatoglossal and palatopharyngeal folds which extend into the palate itself and the muscle of the uvula with the exception of the tensor veli palatine. The flexible frame for the soft palate is due to the aponeurosis of Tensor palati muscle. The muscles are innervated by the mandibular nerve of the soft palate and are supplied by nerve fibers which leave the medulla in the cranial part of the accessory nerve which reach the pharyngeal plexus via the vagus nerve.
Snoring, hypopnea and obstructive sleep apnea (OSA) are caused by the vibrating soft palate; soft tissue of the nasal and oral pharynx, relaxed tongue moving backwards towards the oral and laryngeal pharynx which blocks the air passageway through the pharynx, or lingual compartment during sleep obstructing air passage through the naso, oro and laryngpharynx. Other causes include: the loose tissue within the mouth cavity including the flaccid tongue, the pharyngeal folding, tonsillar pillars, and the muscular uvula with the soft palate-called the pharyngeal arch that has a propensity to vibrate as tidal air flows past narrow air passages during sleep causing snoring and obstructive sleep apnea.
Snoring is an inspiratory sound, which arises in the course of a person's sleep due to the narrowing of the naso, oro, and laryngo-pharyngeal airway with inspiratory airflow in the narrow passages. The sounds of snoring are generated by vibration of soft tissues of oropharynx such as the soft palate, uvula, tongue, lips, the posterior faucial pillars of the tonsils, pharyngeal folds, posterior, and lateral pharyngeal wall and epiglottis in the upper airway, however, the soft palate and the uvula are the main culprits (FIGS. 1, 2, 3, 4).
Many causes for the narrowing of the nasal pharyngeal airway (FIG. 3, 4) during sleep exist besides the flaccid soft palate and the tongue role. People who snore rarely make snoring sounds when breathing while awake in the same position that is associated with snoring when asleep (FIGS. 1, 2). The reason being, that the person when awake has watchful control of various muscles of the upper airway that prevent the vibrations that cause snoring to occur (FIG. 1). During sleep, the motor neurons that control skeletal muscles are inhibited from sending the instructions (to make them active) that increase the tone of these muscles. This physiological process in sleep results in flaccid muscles that permit soft tissue to sag and collapse into the pharyngeal wall that results in snoring with OSA strikes (FIGS. 2, 3).
Up to 45% of all adults snore sporadically with about 25% being constant snorers. It is known that snoring increases with advancing age. This has been observed that about 50% of men and 40% of women are habitual snorers by the age of 60 (Lugaresi et al, “Snoring: Pathogenic, Clinical and Therapeutic Aspects”, Reported in Principles and Practice of Sleep Medicine (Kryger et al, Editors (1989) at pp. 494-500). There are estimates of 28 million people suffering from OSA in USA.
One needs to discriminate the difference between non-obstructive snorers (FIG. 2) from the obstructive sleep apnea snorers (FIG. 3) and hypopnea (FIG. 2). Hypopnea is a medical term that involves episodes of shallow breathing or an abnormally low respiratory rate. This may not be due to naso-oro-laryngo-pharyngeal airways. This differs from sleep apnea in that there remains some flow of air. Hypopnea events may happen while asleep or while awake. It's abnormally shallow breathing lasting at least ten seconds. In the context of diagnosis and treatment of sleep disorders, a hypopnea event is not considered to be clinically significant unless there is a 30% or greater reduction in air flow lasting for 10 seconds or longer with an associated 4% or greater desaturation in the person's oxygen levels, or it results in arousal or fragmentation of sleep. During hypopnea, there is airflow, through a much-reduced level, which leads to not getting enough oxygen. The apnea-hypopnea index or respiratory disturbance index (AHI) is an index of severity that combines apneas and hypopneas. Combining them both gives an overall severity of sleep apnea including sleep disruptions and oxygen desaturation (a low level of oxygen in the blood).
An apnea index or AI shows the average number of apneas per hour of sleep. A hypopnea index or HI shows the average number of hypopneas per hour of sleep. An apnea and hypopnea index or AHI shows the average number of apneas and hypopnea per hour of sleep. Some doctors use the term of respiratory disturbance index or RDI, instead of AHI. The apnea-hypopnea index calculated by dividing the number of apneas and hypopneas by the number of hours of sleep. AHI values are categorized as 5-15 Mild, 15-30 Moderate, and above 30 listed as Severe. Example: Apnea+Hypopnea divided by actual sleep time, and then multiply by 60. 200 Apnea 200 Hypopnea=400 Total Events; 420 Actual Sleep time (7 hours). Divide 400 by 420=0.95×60 (minutes per hour)=57 AHI (Severe OSA).
The physiological terms used to describe various types of breathing associated with snoring and obstructive sleep apnea breathing difficulties are as follows. Eupnea—normal breathing; Apnea—absence of breathing; Bradypnea—decreased breathing rate; Dyspnea or shortness of breath—sensation of respiratory distress; Hyperaeration/Hyperinflation—increased lung volume; Hyperpnea—fast and deep breathing; Hyperventilation—increased breathing that causes CO2 loss; Hypopnea—slow and shallow breathing, Hypoventilation—decreased breathing that causes CO2 gain, and Labored breathing—physical presentation of respiratory distress. Obstructive sleep apnea (OSA) is due to complete blockage of air to the larynx due to mechanical soft tissue blockage (FIG. 3) by Naso-Oro-laryngo-pharyngeal tissue.
TYPES OF SLEEP APNEA: There are three types of sleep apnea. They are as follows:
1. Obstructive sleep apnea (OSA) is the common form of the condition when the tissues of the naso-oro-laryngeal-pharynx obstruct breathing during sleep. These pauses in breathing are called apneas (literally, “without breath”), and usually last 20 to 40 seconds. More than 28 million suffer from OSA in the US and its occurrence in the adult population is estimated to be 3-4% in women and 6-7% in males. People who suffer from weight gain, obesity, craniofacial syndromes (mostly genetic), repair of cleft palpate, Down's syndrome, small mandible etc. have a higher risk of developing obstructive sleep apnea than most individuals. Our invention is mainly intended to treat these conditions causing obstructive sleep apnea.
2. Central sleep apnea is due to a neurological condition as a result of a head injury, stroke, or various central nervous system disorder, or heart failure. Patients with central sleep apnea should avoid using sedatives, narcotics, and alcohol. Treating the primary etiology will in most cases eliminate the condition. Treatment for central sleep apnea syndrome includes the use of medications. They are medroxyprogesterone, acetazolamide, theophylline, and nicotine. Avoid central nervous system depressants such as sedatives and alcohol. Many patients suffering from central sleep apnea also have some degree of obstructive sleep apnea unfortunately the primary etiology may be terminal.
3. Mixed sleep apnea is due to physical oropharyngeal airflow obstruction associated with central (CNS) etiology. It is a rare condition that is the most dangerous form of sleep apnea. Therefore, it is the most difficult to treat. The present invention provides a treatment for this form of obstructive sleep apnea.
Symptoms of Obstructive Sleep Apnea are frequent cessation of breathing (apnea) during sleep. A sleeping spouse or companion notices repeated silences from your side of the bed with sudden awakenings to restart breathing with choking or gasping during sleep to get air. Loud snoring, awakening in a sweat during the night due to lack of oxygen with an increase of carbon dioxide build up in the blood, waking up restless in the morning after a night's sleep with or without headaches also takes place in these patients. Sore throat, dry mouth in the mornings, daytime sleepiness including falling asleep at improper times, when driving to work, at meeting and conferences with fatigue are also noticed. Mood changes like irritability, anxiety, depression, trouble concentrating, forgetfulness reduced and dwindling sex drive, unexplained weight gain, increased urination and/or nocturia, frequent heartburn, gastro-esophageal reflux disease (GERD), and heavy night sweats can occur in the patients with obstructive sleep apnea.
Studies by Lee et al, shown that the oxygen desaturation associated with sleep events were detected in all patients with OSA, but not in simple snorers. (Lee C H, Mo J H, Kim B J, Kong I G, Yoon I Y, Chung S, Kim J H, Kim J W, Arch Otolaryngol Head Neck Surg. Evaluation of soft palate changes using sleep video fluoroscopy in patients with obstructive sleep apnea. 2009 eb; 135(2):168-72). When awake, inspiratory efforts increased the length and angle of the soft palate (SP) in patients with OSA but not in simple snorers. Elongation and angulations were greatest during desaturation sleep events and least during awake (FIGS. 1, 3). In normal oxygenation events, changes in the soft palate (SP) were significantly larger in patients with OSA than in simple snorers (P<0.01 for SP length; P=0.03 for SP angle). These studies showed that the SP was considerably elongated and angulated in patients with OSA even when awake. Hence, the treatment of snoring is differentiated for the sake of treatment: 1. to prevent production of sound during sleep, 2. to treat the obstructive sleep apnea, which has serious health consequences. Our invention is intended for treatments of both conditions.
There are no effective FDA approved drug treatments for obstructive sleep apnea. Nevertheless, a clinical trial of the anti depressant mirtazapine (Brand name: Remeron, Avanza, Zispin) has shown promising results in the treatment of Obstructive Sleep Apnea, but it causes weight gain and sedation (“First Effective Drug for Sleep Disorder Identified”. ScienceDaily.com. June 2003). It is a tetra cyclic antidepressant (TeCA) used primarily in the treatment of depression. The drug may treat as a hypnotic, antiemetic, appetite stimulant, and for the treatment of anxiety. Mirtazapine is not a SSRI reuptake inhibitor. It disinhibits dopamine and norepinephrine activity in various parts of the brain in the pleasure centers such as the ventral tegmental area (VTA) which causes a pronounced antidepressant and anxiolytics response due to the release of the neurotransmitters dopamine and norepinephrine. Beside its close analogues, mianserin and setiptiline, mirtazapine is one of the small number of noradrenergic and specific serotonergic antidepressants (NaSSAs) that can be tried on OSA.
Other drugs that are tried are serotonin uptake inhibitors (SSRI) such as fluoxetine, tryptophan, protriptyline, oral methylxanthine, and theophylline (chemically similar to caffeine), amphetamines stimulants, and anti-narcoleptic medications such as modafinil. A course of anti-inflammatory steroids such as prednisone (or another glucocorticoid drug) is given to reduce the lymphoid tissue of the naso-oropharyngeal air passages if enlargement of the lymphoid tissue is found when the allergic conditions are suspected.
A basic treatment for snoring and obstructive sleep apnea involves having the patient sleep in the prone position or on his/her side. This can be put to use by sewing an object into the back of the snorer's clothes. In an obese person, treatment includes weight loss. These patients avoid use of CNS depressing drugs, cigarettes, or alcohol prior to bedtime to prevent or reduce the loss of oropharyngeal muscle tone.
Nasal and oropharyngeal obstruction due to enlarged tonsils and adenoids treated or relived by surgical removal. Surgical repair of deviated nasal septum improves snoring. Snoring can be due to genetics with some being predisposed towards an anatomical narrowing across the nasal-oral-laryngeal-pharynx resulting in the reduced pharyngeal passageway caused by a lack of muscle tone. Other anatomical conditions contributing to the narrowing of the naso-oro-laryngo-pharyngeal passageway include choanal atresia, chrono polyp, nasal septal deviation, nasal and pharyngeal cysts, macroglossia, retrognathia, micrognathia and countless other etiologies. (Leung et al, “The ABZzzz's of Snoring”, Post Graduate Medicine; Sep. 1, 1992).
Snoring and OSA might be aggravated by alcohol drinks or drugs (such as tranquilizers, hypnotic, sleeping pills, and antihistamines) taken prior to bedtime. Smoking is also held responsible for snoring. The cigarettes may irritate the mucus membranes of the upper airway and oropharynx causing swelling and increased mucus production. When snoring is caused by nasal allergy or an upper respiratory tract infection, these conditions can be treated with antiallergic treatment (Douglas N J. “The Sleep Apnoea/Hypopnoea Syndrome And Snoring”, British Medical journal, 1993, Vol. 306:1057-60; Leung et al, IBID)
Anti-snoring and anti OSA devices abound in the medical device market. Some of them are shown to be effective when they pull or hold the mandible (lower jaw) forward and upward and elevate the tongue when the muscles of the mandible relax, so that the tongue does not occlude the air passageway drifting inferiorly and posteriorly while sleeping to prevent the passage of air (FIG. 1). Most anti-snoring devices accomplish this task by moving the lower jaw forward and holding that position against a rigid upper dental component fixed to the upper teeth in the immobile maxilla and to the moving lower teeth in the mandible. The disadvantages in using the above prior art devices are that they require expert qualified licensed lab services for fitting of the anti-snoring device to the user's mouth. Such devices could cause permanent irremediable changes in the bite of the user and permanently alter the jaw position. This requires a dentist to monitor the anti snoring device fitting. There is a need for an anti-snoring device that does not rigidly bind to the dental structures of the user's mouth and that does not require professional supervision or assistance in its fabrication, or monitoring of the dental bite changes and mandibular changes. In addition, the anti-snoring device should not pit the lower jaw against the upper jaw. These devices do not include an intra oral dental overlay to support the tongue against the palate and keep the palate of the user's mouth from reverberating (snoring) during mouth breathing. Our invention overcomes these drawbacks.
Snoring and obstructive sleep apnea can also be managed by the use of a positive pressure generator and facemask. In this procedure, a mask covers the nose and mouth or nose or mouth and delivers air under pressure. The standard method is known as “Continuous Positive Airway Pressure” (CPAP) treatment that requires the patient to wear a mask in which air is blown into the nostrils to keep the airway open. Patient compliance is poor due to discomfort and side effects. These machines pump air through a hose and nose/mouth facemask to keep air passages clear and open. CPAP pneumatically splints the upper airway. Use of the devices can cause the subject to become non-complaint due to difficulty in its use due to discomfort problems during sleep. Problems that may occur with CPAP include restless sleep, dryness of nose, throat, and nasopharyngeal tract, cough, excessive dreaming during early use, nasal congestion, runny nose, sneezing, irritation of the eyes and the skin on the face, abdominal bloating, and leaks around the mask when it does not fit properly.
The patient may be able to limit or stop some of the side effects. The doctor may be able to adjust your CPAP to reduce or eliminate problems to make sure the mask or nasal prongs fit you properly where air should not leak around the mask. The use of a humidifier, corticosteroid, nasal sprays to reduce nasal congestion, irritation, and drainage used if beneficial.
Users of this method of treatment may need to talk to a doctor about trying a CPAP machine that will help to reduce discomfort caused by too much constant pressure in the user's nose. If this does not improve discomfort, ask your physician about trying a bi-level positive airway pressure machine (BiPAP-VPAP or variable positive airway pressure), which uses a different air pressure when you breathe in when you exhale. BiPAP may work better than standard CPAP for treating obstructive sleep apnea in people who have heart failure. BiPAP machines are more expensive than CPAP machines.
When one is using CPAP or BiPAP, the person needs to see their doctor and sleep specialist regularly. There may be a need for more sleep studies to adjust the CPAP machine and check whether the treatment is working. The sleep studies and the CPAP machines are expensive. A patient can rent a CPAP machine before purchasing one. The most common problem with CPAP is lack of compliance. This means that people do not use the machine every night because the machine is uncomfortable. The patient may remove the machine as they sleep which leaves the patient sleepy the next day due to repeated interruption during sleep.
In 2008, a device with Nasal Expiratory Positive Airway Pressure (EPAP) increasing device named Provent™ was introduced by Ventus Medical. The provent device contains two pinhole-size valves, one over each nostril. The valves let air in easily—most people breathe through their nostrils while asleep—but there is resistance as the user exhales. That resistance creates a backpressure in the airways, dilating the muscles that would otherwise collapse in the middle of the night. In the morning, the patch removed; a new one used every night. This device is not effective in all cases. Some people do experience difficulty inhaling and exhaling air, and are uncomfortable due to the buildup of positive pressure during exhaling and take longer to fall asleep with the device on. The study by Berry et al. studies show that the nasal EPAP device improved subjective daytime sleepiness compared to the sham treatment in patients with OSA (Berry R B; Kryger M H; Massie C A. A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial. SLEEP 2011; 34(4):479-485). It is ineffective in severe form of obstructive sleep apnea.
A more recent treatment option to obstructive sleep apnea includes the implantation of rigid inserts in the soft palate to provide structural support. This is both invasive and only effective for mild to moderate cases of obstructive sleep apnea. Alternative treatments are even more invasive and drastic: including tracheostomy, genioglossus advancement or stimulator, hyoid suspension, tongue reposition, and tissue ablation (somnoplasty or uvulopalatopharyngoplasty (UPPP)).
If all else fails, sleep apnea can be treated by maxillomandibular advancement. It is a complex operation, in which the maxilla holding the upper teeth and the mandible holding the lower teeth are surgically cut, and the lower part of your face moved forward approximately 12 millimeters. In this complex surgical procedure, the airway in the back of the throat is expanded to relieve the obstructive sleep apnea. This undertaking is advised only for disabling obstructive sleep apnea patients in whom other treatments have failed. Other treatments include reduction of the size of the soft palate, laser-assisted uvulopalatoplasty, reduction of the tongue base either with laser excision or radiofrequency ablation, Genioglossus Advancement, Hyoid Suspension in which the hyoid bone in the neck are attempted to treat this condition. In rare intractable cases, tracheostomy is the only effective treatment for sleep apnea.
Due to many associated disadvantages, complications and high failure rate, these tissue ablation methods and radical surgeries considered as a last resort. Other options for treating snoring are found with surgical techniques where there are removal of enlarged adenoids, tonsils, and host of other therapies recommended. Surgical removal of the uvula, distal portion of the soft palate, the anterior tonsillar pillars, and the redundant lateral pharyngeal wall mucosa said to increase the size of the air passageway allowing unobstructed movement of air through the pharynx. Rates of success of the uvulopalatopharyngoplasty reported to be in a range from 15% to 65% (Douglas, “The Sleep Apnoea/Hypopnoea Syndrome And Snoring”, British Medical journal, 1993, Vol. 306:1057-60). In some instances, surgical repair of a deviated nasal septum may improve snoring but not OSA.
Consequences of snoring and obstructive sleep apnea are exhaustion due to lack of sleep, interfering with work, and sleepiness while driving. Obstructive sleep apnea causes high blood pressure, depression, irregular heartbeats, heart failure, coronary artery disease, and stroke. If the person is overweight, bariatric surgery may help to lose weight and improve sleep apnea.
Snoring and obstructive sleep apnea patients with decreased pulmonary function such as emphysema, asthma, chronic obstructive lung diseases (COPD), and congestive heart failure are shown to suffer from severe apnea. Cessation of breathing during snoring, or obstructive sleep apnea results in lack of oxygen due to an obstructed nasopharyngeal passageway that deprives the body of sufficient oxygen with oxygen desaturation arises. Lack of oxygen may cause the brain to awaken the sleeper to take a breath without fully waking. This may happen dozens and even hundreds of times a night. The snorer and OSA patients do not get sufficient sleep. Being aroused from deep REM sleep on a repetitive basis increases heart rate and blood pressure with associated risks of heart attack and stroke. Furthermore, narcolepsy resulting from exhaustion can cause a lack of attention for the snorer and OSA sufferers during waking hours causing a drop in productivity and accident proneness at work, driving, and other daily activities.
Several attempts are made to treat OSA and snoring using many implants and devices placed in either the tissue of the soft palate or the pharyngeal airway as disclosed in U.S. Pat. No. 6,250,307; U.S. Pat. No. 6,523,542; and U.S. Pat. No. 6,431,174 and U.S. Pat. No. 6,601,584.
Another technique to treat OSA and snoring includes debulking tissue by applying radio frequency ablation to the tongue base or of the soft palate to debulk the tissue of the tongue or palate, respectively. This technique illustrated in U.S. Pat. No. 5,843,021 (Powell et al. “Radiofrequency tongue base reduction in sleep-disordered breathing: A pilot study”, Otolaryngol. Head Neck Surg., Vol. 120, pp. 656-664 (1999). U.S. Pat. No. 6,161,541 for OSA include stimulation of the hypoglossal nerve (Eisle et al., “Direct Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea”, Arch. Otolaryngol. Head Neck Surg., Vol. 123, pp. 57-61 (1997)). There are methods described to place struts or magnet in the tongue (U.S. 2005/0199248 AD, U.S. 2004/0139975, U.S. 2004/0149290). U.S. Pat. No. 7,845,357 B2 describes Tongue Implant for Sleep Apnea. Many of these are invasive procedures, and patients are not willing to undergo these drastic procedures. Besides the expenses, the success rate is not guaranteed.
U.S. Pat. No. 5,569,679 discloses the use of nasal solution 10%-16% of methylsulfonylmethane (MSM) drops for the treatment of anti snoring method. This nasal spray is too simplistic to a complicated anatomically related snoring with or without obstructive sleep apnea whose pathophysiology is not in the nose.
U.S. Pat. No. 5,921,241 discloses an anti-snoring device including a moldable dental overlay for covering the lower teeth of the user and for maintaining the tongue in contact with the palate to prevent airflow from causing the palate to reverberate during mouth breathing.
U.S. Patent Application Publication Number: U.S. Patent Application Publication Number: 2004/0153127 A1 invention provides electrical stimulation that causes the oropharyngeal muscles to contract during sleep using one or more micro stimulators injected into or near these muscles or the nerves which innervate them.
U.S. Patent Application Publication Number: US 2007/0233276 A1 describes the method and apparatus include placing a tissue contractor within the tongue tissue. This is invasive procedure and may create discomfort and complication after surgery.
U.S. Pat. No. 6,418,933 B1 discloses an anti-snoring device has maxillary and mandibular bite forms with outwardly extending pivots which are mounted to the bite forms by frameworks which are at least partially embedded in the bite forms.
U.S. Pat. No. 5,499,633 shows two bite forms that may be joined so that the user's mandible projects forwardly of its normal position in order to reduce snoring.
U.S. Patent Application Publication Number: 2005/0178392 A1 discloses a small piece of cloth tape or other porous hypo allergenic material with a hypoallergenic adhesive on the back affixed to the lips before sleeping. This may not be effective in preventing the vibration of the soft palate and snoring with or without obstructive sleep apnea.
U.S. Pat. No. 7,016,736 B2 discloses a submental electrical stimulation of the supra hyoid muscles at the floor of the mouth, and does not address the snoring due to vibration of the soft palate and uvula.
Numerous management techniques have been described, and none of these treatments have proved adequate. Most of the therapies are inadequate to treat snoring and obstructive sleep apnea. Surgery for the condition is fraught with fear and complications besides high cost and high rate of failure. Hence, snoring and obstructive sleep apnea remains a serious health problem. With increasing obesity (Syndrome X), snoring with or without obstructive sleep apnea is increasing in the general population along with type II diabetes. Accordingly, there has been a need for improved management techniques to reduce or eliminate snoring and obstructive sleep apnea using simple and safe methods. The devices in the present inventions designed to treat snoring and obstructive sleep apnea with minimum or no complications, the least amount of disadvantage, and highest amount of user compliance with low cost.